NCT04552665

Brief Summary

The purpose of the KODEX EPD Field study is to evaluate the performance of the KODEX-EPD system and collect procedural data and medical images for Philips' internal research and development activities (R\&D) related to the KODEX-EPD system, as well as for marketing and publication purposes. The KODEX-EPD system is an imaging system that will allow for real time visualization of the catheters in your heart during your procedure, as well as display cardiac images of your heart in several different formats.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 17, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

October 28, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2023

Completed
Last Updated

June 8, 2023

Status Verified

June 1, 2023

Enrollment Period

2.6 years

First QC Date

August 18, 2020

Last Update Submit

June 6, 2023

Conditions

Cardiac Arrhythmia

Outcome Measures

Primary Outcomes (1)

  • Cardiac Images

    The KODEX-EPD system is an imaging system that will allow for real time visualization of the catheters in your heart during your procedure, as well as display cardiac images of your heart in several different formats.

    Through study completion, an average 1 year

Study Arms (1)

Adults

Patients who have cardiac arrhythmia

Device: KODEX-EPD system

Interventions

KODEX-EPD systemDEVICE

To evaluate the performance of the KODEX-EPD system and collect procedural data and medical images for Philips' internal research and development activities (R\&D)

Adults

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who undergo a cardiac ablation

You may qualify if:

  • Cardiac Ablation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Staten Island University Hospital North Campus

Staten Island, New York, 10305, United States

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Marcin Kowalski, MD

    Staten Island University Hospital North

    PRINCIPAL INVESTIGATOR

  • Anneleen Viville

    EPD Solutions, A Philips Compagny

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2020

First Posted

September 17, 2020

Study Start

October 28, 2020

Primary Completion

June 6, 2023

Study Completion

June 6, 2023

Last Updated

June 8, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)